Malerba Mario, D Amato Massimo, Radaeli Alessandro, Giacovelli Giampaolo, Rovati Lucio, Arshad Sayed H, Holgate Stephen T
Department of Internal Medicine, University of Brescia, Spedali Civili. Pzza Spedali Civili 1. 25100 Brescia -Italy.
Curr Pharm Des. 2015;21(26):3835-43. doi: 10.2174/1381612821666150407101614.
Andolast is a new airway specific anti-inflammatory agent. The aim of the present multicentered, randomized, placebo controlled study is to investigate whether andolast produces a therapeutic response greater than placebo in asthmatic adult patients.
549 symptomatic patients with mild or moderate asthma were randomized to receive andolast at three different doses (2, 4, or 8 mg t.i.d.) or placebo for 12 weeks. Efficacy and safety were evaluated during scheduled visits with pulmonary function tests, peak expiratory flow rate (PEFR), symptoms diary and quality of life questionnaire. The primary outcome included the changes (expressed as percent variation) from baseline of the forced expiratory volume in one second (FEV1) absolute values after 12 weeks of treatment.
One hundred and thirty one (131) patients were treated with andolast at the dose of 2 mg t.i.d., 128 patients at the dose of 4 mg t.i.d., 144 at the dose of 8 mg t.i.d. and 146 with placebo. Andolast produced a dose dependent significant improvement over placebo on airflow obstruction, as shown by the changes in FEV1 (andolast 2, 4, 8 mg vs. placebo: p = 0.011), especially in a subgroup of patients showing moderate airways obstruction (FEV1<80%pred). The mean number of asthma control days and free days significantly increased, the average number of inhaled puffs of short-acting α2-agonists used as rescue medication was significantly reduced as compared with placebo. Andolast also significantly decreased the incidence of asthma exacerbation episodes.
Andolast proved to be significantly more effective than placebo in improving airflow, and in controlling asthma symptoms both during day and night.
安多乐是一种新型的气道特异性抗炎药。本多中心、随机、安慰剂对照研究的目的是调查安多乐在成年哮喘患者中是否产生比安慰剂更大的治疗反应。
549例轻至中度哮喘症状患者被随机分为接受三种不同剂量（每日三次，每次2、4或8毫克）的安多乐或安慰剂治疗12周。在定期访视期间，通过肺功能测试、呼气峰值流速（PEFR）、症状日记和生活质量问卷评估疗效和安全性。主要结局包括治疗12周后一秒用力呼气量（FEV1）绝对值相对于基线的变化（以百分比变化表示）。
131例患者接受每日三次2毫克剂量的安多乐治疗，128例接受每日三次4毫克剂量的安多乐治疗，144例接受每日三次8毫克剂量的安多乐治疗，146例接受安慰剂治疗。如FEV1的变化所示，安多乐在气流阻塞方面比安慰剂产生了剂量依赖性的显著改善（安多乐2、4、8毫克与安慰剂相比：p = 0.011），特别是在显示中度气道阻塞（FEV1<预测值的80%）的患者亚组中。与安慰剂相比，哮喘控制天数和无发作天数的平均数显著增加，用作急救药物的短效α2激动剂的平均吸入次数显著减少。安多乐还显著降低了哮喘加重发作的发生率。
事实证明，安多乐在改善气流以及控制白天和夜间哮喘症状方面比安慰剂显著更有效。
